Class II — Canon Inc.
| Recalling firm | CANON INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. |
| Product | Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. |
| Quantity | 468 units |
| Distribution | Nationwide Distribution (USA) |
| Initiated | 2010-11-01 |
| Classified | 2012-08-24 |
| Terminated | 2014-01-07 |
| Recall number | Z-2265-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Canon Inc. (Z-2265-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62828/
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